Bone fractures are often repaired by securing a bone plate across the fracture. Depending upon which bone is to be treated, the bone plate may be straight or curved to match the contour of the bone for which it is designed. Bone plates may also be provided in many shapes and sizes. In cases where a bone is severely comminuted or if bone segments are missing, the use of bone plate and screw systems promotes healing of the fracture by providing a rigid fixation or support structure between the bone and the plate.
Bone plates may be secured to the bone in a number of ways. An existing solution is a plate and screw system where screws, called locking screws, are locked in the plate. First, a locking screw is threaded through an opening in the plate and into the bone. Then the locking screw is secured to the bone plate via threads on the head of the locking screw that cooperate with threaded openings in the bone plate. This secures the plate with respect to the bone and provides rigid fixation because the relationship between the plate and locking screw(s) is fixed. Because the threads on the head of the locking screw interdigitate with the threads in the plate opening, the plate and screws(s) form one stable system, and the stability of the fracture can be dependent upon the stiffness of the construct. Locking a screw into the plate can achieve angular and axial stability and eliminate the possibility for the screw to toggle, slide, or be dislodged, reducing the risk of postoperative loss of reduction.
However, although locking screws may reduce the incidence of loosening, they have limitations. Locking screws provide only one fixed angle relationship between the plate and the screw(s). They have a limited insertion angle because the threads of the head mate with the threads of the hole in one way only. The longitudinal axis of the screw aligns with the central axis of the hole, and no angular variation is allowed. In short, locking screws are unidirectional, limiting their use in some instances. For example, when treating a severe fracture, bone fragments may be shattered and in irregular positions. Although a surgeon may wish to obtain the benefits of a locking screw and bone plate used together, the pre-determined angle at which the locking screw extends from the plate may not be the angle that would allow the surgeon to “grab” (or seize, or otherwise secure) the desired, random bone fragment. Rather, screws with more angular flexibility (such as compression screws) may be required. Moreover, locking screws secured in a plate have a limited capability to compress bone fragments, since once the screw is fully rotated to lock with the plate, it can rotate no further to compress the plate to the bone. Conversely, there may be situations where the screw rotates sufficiently to capture bone, but does not rotate sufficiently to lock to the plate.
In short, while locking screws were useful to provide rigid fixation, they often could not perform other functions typically performed by traditional non-locking or compression screws (also referred to as cortical or cancellous screws). Although non-locking screws are secured into bone in the same way that locking screws are, they are not secured to the plate. Their heads are typically rounded where they contact the bone plate and they do not have threads that lock into the plate. Thus, while not optimal in providing a rigid construct between the screw and plate, they can be inserted at various angles because they are not limited by the thread-to-thread contact of locking screws with the bone plate.
Given the unique contributions of each of locking and non-locking screws, bone plating systems were developed that provided surgeons the option of using both types of screws in an installation. In this way, surgeons could choose intra-operatively whether to use the bone plate with compression screws, locking screws, or a combination of both and thus more effectively tailor the installation to the particular situation.
In some embodiments, these systems provide plates with some threaded holes (that may receive either locking screws or non-locking screws) and some non-threaded holes (for non-locking screws). Some systems provide partially threaded slots to allow either non-locking or locking screws to be used together. Such combination slots provide surgeons with the intra-operative choice about whether to use the plate with locking screws, non-locking screws, or a combination of both. These combination slots typically have a partially threaded opening that can receive either a compression screw or a locking screw. However, because these combination slots are only partially threaded, the locking screw(s) may not be able to maintain the fixed angular relationship between the screw(s) and plate under physiological loads. Specifically, the locking screws within the plate are only partially captured and thus only partially surrounded by threads. Under high stress and loading conditions, the slot may distort and allow the fixed angular relationship between the locking screw and plate to change. This can result in loss of fixation or loss of established intra-operative plate orientation. Moreover, the locking screw can still only be inserted at a single angle—the predetermined angle defined by the manufacturer.
Additionally, current bone plate and screw systems still limit a surgeon's ability to both (a) lock a fastener with respect to the bone plate, but still (b) allow the fastener to extend from the bone plate at various angles. Locking screws lock into the plate, but only in a single angular configuration, and non-locking screws allow various angle configurations, but they do not provide a stable construct with the plate. Accordingly, none of these options allow a surgeon to capture bone fragments that do not fall in line with the axis of the opening provided on the plate in a rigid fashion. Thus, currently available options can still lead to mal-alignment and poor clinical results.
There have been some attempts to provide polyaxial locking systems. For example, one effort includes providing holes that accept fixed angle locking pegs and multidirectional locking pegs, with a threaded cap inserted over the multidirectional peg to hold it in place. Such a system can be cumbersome to use because, although the multidirectional peg can be inserted at any angle, the surgeon then needs to thread a small cap onto the top of the peg head and into the plate, requiring an extra step, extra time, and extra instrumentation. Such systems also fail to allow the use of non-locking members in conjunction with the locking and multidirectional pegs.
Other systems that have attempted to offer polyaxial fixation include providing a bone plate with deformable inserts at the hole peripheries made out of a deformable material, with the remaining part of the plate made of titanium. The plate is manufactured and the deformable inserts are then pushed into the hole peripheries and engaged in place by deformation and pressure. When screws are inserted, the deformable inserts deform and are compressed between the screws and the edges of the holes of the plate, which holds the screws and inserts in place. There are challenges with such systems, however. First, the deformable inserts cannot be used with non-locking screws. Second, the deformable inserts do not have the strength to receive and hold a regular locking screw. Thus, the unavailability of non-locking screws and regular locking screws do not provide the surgeon with options. Finally, plates with deformable inserts are more expensive to manufacture than regular bone plates.
Accordingly, there exists a need for an improved bone plating system that overcomes the deficiencies of the prior art. There is a need for a system that provides a stable connection between a bone and a bone plate using a fastener that permits different angles to be obtained between the bone plate and the fastener, while the fastener also locks into the bone plate. This would allow surgeons to capture random bone fragments that are in irregular positions, for example, in cases of severe fractures with highly fragmented bone fragments. In these and other cases, it would be advantageous to provide a fastener and plate system that allows the surgeon to choose the angle at which the screw is inserted through, and rigidly affixed in, an opening of the plate.
Such an improvement would allow a surgeon to direct the fastener toward bone fragments that are not necessarily located directly beneath the opening in the plate. It would also provide flexibility in the placement of the plate in relation to the bone fracture. Allowing surgeons to choose the angle at which the fastener is inserted into the plate would lead to better tailoring of the system to the specific nature of the bone fracture to be treated. It would also allow surgeons to adjust their strategy as necessary after the surgical site has been accessed, but prior to insertion of the fastener into bone material. Additionally, embodiments described herein provide for a more secure polyaxial insertion than what is available in known systems which contain a plate with a deformable insert.